GNS561 and Trametinib for Advanced KRAS-Mutated Cholangiocarcinoma
This study is testing a combination of two drugs, GNS561 and trametinib, for patients with advanced cholangiocarcinoma (bile duct cancer) that has a specific genetic change called a KRAS mutation. You might be able to join if your cancer has progressed after standard chemotherapy and you have a KRAS mutation. Researchers want to see how safe the drug combination is and how well it shrinks tumors. The study is currently recruiting about 98 participants.
- Study design
- This is an open-label, multi-center Phase 1b/2a study, meaning both you and your doctors will know which drugs you are receiving. It aims to enroll about 98 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will measure how well the treatment works for up to 11 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Combination of GNS561 and Trametinib in Patients With Advanced KRAS Mutated Cholangiocarcinoma
At a glance
Conditions
Where it's being run
11 sites across 9 statesStudy leadership
- Pejvack MOTLAGH, CMO · STUDY_DIRECTOR · Genfit
Who to contact
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What this trial measures
- Incidence of dose limiting toxicity (DLT) of GNS561 with trametinib (Phase 1b)At the end of Cycle 1 (each Cycle is 21 days)
Defined as Treatment Emergent Adverse Event (TEAE) being at least possibly related to study drug: With Grade ≥ 3 (using NCI CTCAE Version 5.0 or higher as applicable) such as specified in the protocol
- Objective response rate (ORR) of the combination of GNS561 with trametinib (Phase 2a)Up to 11 months (estimated)
Defined as the proportion of patients with a best overall response of complete response (CR) or partial response (PR) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)